VOCO Profluorid Varnish - Fluoride-containin dental desensitising varnish - VOCO GmbH

Duns Number:316699578

Device Description: Fluoride-containin dental desensitising varnish (5% NaF)

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More Product Details

Catalog Number

2232

Brand Name

VOCO Profluorid Varnish

Version/Model Number

2232

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

LBH

Product Code Name

Varnish, Cavity

Device Record Status

Public Device Record Key

d091e4c0-49dc-4f91-8d75-2f0d1e640624

Public Version Date

February 07, 2019

Public Version Number

3

DI Record Publish Date

August 31, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"VOCO GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 40
2 A medical device with a moderate to high risk that requires special controls. 396
U Unclassified 5